Plan. Launch. Manage. Scale.
Design controls, risk, verification and validation, change, and post-market surveillance: connected on one platform across SaMD, AI/ML, diagnostics, combination products, and hardware. The lifecycle picture stays current as the device evolves and the field reports back.
The product lifecycle, traced end to end.
Design controls, risk, verification and validation, change, and post-market: kept together in connected collections, with LuminLogic IQ on hand as you work.
The DDF as a working document through its lifecycle.
Design, risk, change, submission, and surveillance share the same data model. Lifecycle changes stay connected; the field stays connected to the design.
Design controls
Inputs, outputs, reviews, V&V: configured per project class and connected to the live risk file.
Risk management
ISO 14971 risk file lives next to the design. Hazards link to mitigations, V&V, complaints, and CAPAs.
Change with traceability
A change request links to the requirements, hazards, V&V, and documents it touches, so the impact is visible in one place.
Submissions from source
510(k), EU MDR Technical File, MDSAP, prepared from the same DDF and risk evidence, so you’re not maintaining parallel binders.
Post-market, connected
Keep post-market records, complaints and field reports, in the same system as the DDF and risk file, alongside the design they relate to.
LuminLogic IQ embedded
Ask IQ to summarize requirement changes or draft V&V rationale, every IQ touch logged to the audit trail.
Lifecycle modules, end to end.
See your device through its lifecycle on one platform.
Walk a real DDF from concept to PMS with one of our regulatory engineers.